WO2011135115A1

WO2011135115A1 - System for collecting samples

Info

Publication number: WO2011135115A1
Application number: PCT/ES2010/070311
Authority: WO
Inventors: María MANDIOLA ARIZMENDIARRIETA
Original assignee: Mandiola Arizmendiarrieta Maria
Priority date: 2010-04-29
Filing date: 2010-05-07
Publication date: 2011-11-03
Also published as: ES2368408A1; ES2368408B1

Abstract

System for collecting samples, characterized in that it comprises three parts: an adaptor joined detachably to a tube, and a cap that may or may not be linked to the tube. The adapter has a first wide-mouthed part with walls tending to the vertical, followed by a second inclined part converging towards the final or lower part for connecting and channeling the sample to a tube, which is the tube on which the subsequent sample analysis is performed or processed. The detachable join between the adaptor and the tube may be provided using a weakened fracture line formed by lightly sticking or sealing two separate parts, by pressure, fit or interference, screwing or using an additional intermediate part. Moreover, the cap may or may not be linked to the tube by means of a linking section joined to a ring placed between two projections of the tube, or another system.

Description

SAMPLE COLLECTION SYSTEM-

DESCRIPTION

OBJECT OF THE INVENTION

The object of the present invention is an effective, safe and economical system that facilitates the collection of samples for further study, analysis and / or use in various treatments. Said samples may correspond to body fluids (such as semen, urine or others) in applications intended for assisted reproduction treatments and / or in clinical, veterinary or research laboratories, they may also be of another nature in clinical and hospital applications in general, or be substances of all kinds (fluid or not) in industrial applications such as pharmaceutical, chemical, metallurgical, etc.

The present invention characterizes the special configuration and design of each of the parts and parts that make up the sample collection system so that a faster and easier collection is achieved, avoid the loss of part of the sample obtained, avoid errors of identification, and eliminate the risk of a potential external contamination (microbiological or others).

Therefore, the present invention is circumscribed within the scope of sample collection vessels in general, making special explanatory mention in the cases of semen and urine samples due to the special difficulty involved in collecting them in the currently existing containers. this end.

BACKGROUND OF THE INVENTION

Currently, when collecting samples of certain substances (for example, some body fluids such as semen and urine) for further study, analysis and / or use in various treatments (such as assisted reproduction), or in the laboratory, we encounter several problems:

At the time of sample collection, it is difficult to way to obtain it from the patient, or user, since the operation must be performed with one hand.

In many cases, the collection of the entire volume without loss of a certain part of the sample is very complicated (think for example of semen and others)

The sample is manipulated by the patient or by healthcare personnel (in the reproductive and clinical applications) and by the users (in the rest of the applications) before it can be processed for study, analysis or treatment in the final tube (semen, urine or others, as the case may be), since it has to be transferred to another test tube, which can lead to identification errors, as well as possible external contamination (microbiological, or other origin).

Therefore, it is an object of the present invention to develop a sample collection system that overcomes the above drawbacks; that is to say, that allows a collection in an easy, direct and fast way, that can be manipulated with only one hand, that does not allow losses of the volumes and / or materials collected, nor that intermediate manipulations are necessary, and in which the sample be collected directly in the tube on which the studies, analyzes and / or subsequent treatments will be carried out.

DESCRIPTION OF THE INVENTION

It is an object of the present invention to design a system for the collection of samples of body fluids (semen, urine, etc.), non-body fluids or non-fluid substances, which allows:

- that the collection of the sample is simple for the patient or user,

- which allows the system to be held with one hand, while the sample is collected,

- that nothing is lost of the volume obtained of the substance in question (of the ejaculate in the case of semen),

- That the patient, healthcare staff, or user in general, does not need to manipulate the sample before it is processed, as it will already be collected directly in the final tube, - to avoid the possible identification error when having to manipulate the sample in the laboratory before being analyzed or treated,

- to avoid possible external contamination (microbiological or other) by handling the sample by the patient, healthcare staff or user in general,

- save labor time in the laboratory.

For this we have designed a set of parts or system consisting of a piece (adapter) that will adapt to the final tube in a solidary way (that is, as a single piece that can subsequently be separated into two, adapter and tube), by pressure, through a threaded area, by gluing, sealing or by any other system of union, with the size and shape necessary to solve all the problems we are currently facing.

The system basically consists of three pieces: a first piece or adapter,

a second piece or tube that is connected to the adapter at its end by a separable joint,

a third piece or pressure plug or thread.

The adapter has a general funnel shape in which three distinct parts can be observed:

A high, top or mouth part of the adapter, which will have a sufficient width and length, and a suitable form for the collection of the sample in an easy way, presenting its walls a straight general configuration.

An intermediate part that narrows the mouth of the adapter, adopting a general conical shape, which facilitates the descent of the collected sample.

A final part, of general configuration tending to straight, of dimensions and design such that allow its union to the tube.

The way of joining the tube to the end of the adapter can be in several ways: - The joint can be solidary, that is to say, both pieces are or are joined together and can be separated later (for example, by breaking a weakening line that separates the upper end of the tube from the end of the adapter, or by breaking a slight bonding or sealing between both pieces).

- The connection can also be made by pressurizing both parts (by interference or adjustment). - The adapter and tube joint can be by thread, either by arranging the end part of the adapter with a thread that fits externally on the upper end of the tube or internally.

- Finally, and in certain applications, the union between both pieces can be done by using another or other additional pieces, interposed or intermediate, as help, support and / or support.

Both pieces are finally connected in a segregrable or separable way, so that once the sample is collected and collected, the adapter can be separated from the tube, which is closed by a plug that can be pressed or screwed and with the same quality specifications of the connection between the adapter and the tube.

In order to facilitate the use and non-loss of the cap that is disposed on the tube once separated from the adapter, said cap can be linked to the collection tube by means of a clamping ring or the like. Notwithstanding the foregoing, said cap may also be supplied separately or independently.

Each of the three pieces can be made in any material quality, usually plastic or similar (polyethylene, polypropylene, polycarbonates, polystyrene, polybutadiene styrene or variants), depending on the use to be given (study of the sample or treatment only ), because each one has specific requirements.

These materials may be treated in a special way if required, and there may be passed the necessary quality controls (required according to ISO standards or equivalent, ...). They can be embryotic or not plastics (MEA test or similar), non-pyrogenic or not (LAL test or similar), with endotoxin controls, cytotoxicity control (HSSA test or similar), with mutagenicity tests (Ames test or similar), sterile or not, or in the case of other materials, always according to the needs and the use that will be given to them, and the necessary specifications of each country or community where they are going to be manufactured or commercialized (requirements of the FDA, USP class VI, 51 Ok market in USA, requirements or qualities required by the EC (medical device class II, ...), etc., the system or set of parts can be presented in a sealed and sealed kit.

EXPLANATION OF THE FIGURES.

To complement the description that is going to be made of the system, and in order to help a better understanding of its characteristics, the present descriptive report of a set of drawings is attached, in whose figures, in an illustrative and non-limiting way, they represent the most significant details of the invention. Figure 1 shows a representation, in a vertical plane, system or assembly for sample collection in which four enlarged details of some possible ways of connecting different embodiment between the end of the adapter and the upper end is tube: - The first by weakening (3)

The second by sealing or gluing (13)

The third by threaded union (16)

The room by adjustment or interference (14) The system or assembly is represented in a closed kit (10) with its seal (11).

Figure 2 shows the process of collecting a sample.

Figure 3 shows the assembly formed by the adapter and the tube may be covered by a cover once the sample poured. Figure 4 shows how the tube, with the sample, is covered by a cap.

Figure 5 shows, similarly to Figure 4, how the test tube with the sample is covered by a cap which is attached to the tube

Figures 6 ^a , 7 ^a , 8 ^a and 9 ^a show various partial sections of different adapters in which, in addition to their geometric shapes, the constructive characteristics of some of the possible joints with the tube can be seen.

Figures 10 ^a , 11 ^a and 12 ^a show different plan representations of some of the possible shapes that adapters can take.

PREFERRED EMBODIMENT OF THE INVENTION.

In view of the figures, a preferred embodiment of the proposed invention is described below.

In Figure 1 ^a we can see how the sample collection system (body fluids, non-body fluids or non-fluid substances, as the case may be), object of the invention, consists of the three cited parts; on the one hand the adapter (1), detachably connected with a tube (2), on which a plug (8) can be connected, or not, intended to be placed on the tube (2) once it has been proceeded to the separation between the adapter (1) and the tube (2).

Four extended details of possible connections between the adapter (1) and the tube (2) are highlighted, due to weakening (3), sealing or glueing (13), thread (16) and adjustment or interference (14). On the adapter (1) it is possible to have a cover (4) in case you want to protect the collected sample and not proceed to segregation or separation of the adapter (1) from the tube (2).

A graduation (7) can be arranged on the tube (2) since it will be directly the final element to be processed. In addition, said tube may have its flat bottom, rounded, conical or in any other way that is considered suitable for the application in which it will be used later.

The connection between the adapter (1) and the tube (2) can be carried out in several ways; in the first enlarged detail of figure 1 ^a a line of weakening (3) can be observed that reduces the thickness of the walls, so that in a simple way (manually, or using a knife or cutter) it is possible to perform the separation between both pieces. In the second detail of Figure 1 ^a another form of connection is shown between the adapter (1) and the tube (2), which consists of a seal or glue (13); in this case the separation of both pieces will be done in the same simple way as in the case of the weakening line (3) (that is, manually, or using a knife or cutter).

In the third detail of Figure 1 ^{a it} can be seen that, in the junction zone between the two pieces, the adapter (15) at its end end has a bracketed section (16) that defines an annular housing open inferiorly and which is threaded inside; the upper end of the tube (2) is threaded into it.

Finally, in the fourth detail of Figure 1 ^on an embedded connection of the adapter (17) on the upper end of the tube (2) by interference fit or shown.

Figure 2 ^a shows how, thanks to the mouth of the adapter (1) being wide enough, with a straight general configuration and sufficient length, it is possible to collect the sample, as well as allowing the sample to run through its walls and be channeled to the bottom of the tube (2), where it is collected, avoiding loss of volume. Figure 3 ^a shows the sample collection set, without having separated the adapter (1) from the tube (2), and where the sample already obtained and collected (12) has also been covered by a lid (4) placed over the adapter access port (1). Figure 4 ^a shows only the tube (2) that has already been separated from the adapter (1), then the tube is closed by means of a plug (8), which can be either a pressure plug or a thread.

The connection (9) of the cap (8) with the tube (2), carried out by means of a ring (5) between two projection lines (6) or any other system, may exist or not, as seen in the Figures 5 ^a and 4 ^a respectively.

It is noteworthy, how on the upper end of the tube (2) a thread (23) or projections that allow the fixation of the plug (8) on said end is arranged externally.

Figure 6 ^a shows a detail of the section of the adapter (15) and the shape of its final part, this one presenting a bracketed section (16) that has already been described above. It is also possible to define a series of adapters (17) and (18) (see figures 7 ^a and 8 ^a ) that have the intermediate part with greater or lesser inclination, but that end in a section of straight general configuration (14) that is Makes fit on the upper end of the tube (2). Finally, the adapter (19) of Figure 9 ^a has a configuration such that its final section is designed so that it can be attached to the tube (2) by means of a ring (20), or the like, which is internally threaded.

In Figures 10 ^to 12 different representations are shown in plan adapter, watching in Figure 10 ^to the adapter (1) has a circular cross section, while the adapter (21) of Figure 11 has a slight deformation in order to be able to adapt better for example to the body of a human or animal being, and finally the adapter (22) has an oval shape in figure 12 ^a , there being other possible variants.

The variations in materials, previous treatments, shapes, sizes and arrangement of the component elements, described in a non-limiting manner, do not alter the essence of this invention, being sufficient for reproduction by an expert.

Claims

one . - Sample collection system, characterized in that it consists of three pieces: - a first piece or adapter (1), (15), (17), (18), (19), (21) and / or (22), a second piece or tube (2) that is attached to the adapter by a separable joint (3), (13), (14), (16) and / or (20),

a third piece or plug (8) of snap closure or thread, for closing the tube.

2. - System for collecting samples, according to claim 1, characterized in that the adapter has a general funnel shape that has three distinct parts: - a high, upper part or mouth of the adapter, which will have a sufficient width and length , and a suitable way for the collection of the sample in an easy way, presenting the walls a straight general configuration.

An intermediate part that narrows the mouth of the adapter, adopting a conical general shape, which facilitates the descent of the sample obtained.

3. - Sample collection system according to claim 2, characterized in that the joint connection of the tube (2) to the final part of the adapter (1) is by means of a weakening line (3), or by a light bonding or sealing (13).

4. - Sample collection system according to claim 2, characterized in that the union of the tube (2) to the final part of the adapter (17) is by means of pressure, interference or adjustment of both parts (14), either by inserting the part adapter end externally or internally at the upper end of the tube (2).

5. - Sample collection system according to claim 2, characterized in that the union of the tube (2) to the end part of the adapter is by means of threading of both parts, either having the end part of the adapter a thread so exterior to the upper end of the tube or internally.

6. - System for collecting samples, according to claim 2, characterized in that the union of the tube (2) to the final part of the adapter (15) is carried out by arranging on the bottom of the adapter a bracketed section (16) that defines an annular housing open inferiorly and which is threaded therein in which the upper end of the tube (2) is threaded by means of the external thread (23) with which the upper end of the tube (2).

7. - Sample collection system according to claim 2, characterized in that the union of the tube (2) to the final part of the adapter (19) is carried out by disposing on the end part of the adapter an internally threaded ring (20) .

8. System for collecting samples according to claim 2, characterized in that the adapter has a circular section (1), oval (22), or with a shape that adapts to the body of a human or animal being (21).